Bill Summary
The "Responsibility in Drug Advertising Act of 2025" proposes amendments to the Federal Food, Drug, and Cosmetic Act aimed at regulating direct-to-consumer (DTC) advertising of prescription drugs. Key provisions include:
1. **Advertising Restrictions**: The bill prohibits DTC advertising of newly approved drugs for the first three years post-approval. This applies to all platforms, including social media.
2. **Waiver Provision**: During the third year, drug sponsors can apply for a waiver allowing DTC advertising if the Secretary of Health determines that such advertising would positively impact public health.
3. **Ongoing Monitoring**: After the initial three-year period, the Secretary can further restrict DTC advertising if evidence indicates significant adverse health effects based on ongoing studies and reports.
4. **Implementation Timeline**: The Secretary is required to update regulations within one year of the bill's enactment to ensure proper implementation of these advertising restrictions.
5. **Preservation of Authority**: The bill clarifies that it does not limit the Secretary’s existing authority to regulate drug advertising under other laws.
Overall, this legislation aims to promote responsible advertising practices and protect public health by limiting the promotion of newly approved medications until their safety and effectiveness are better established.
Possible Impacts
The "Responsibility in Drug Advertising Act of 2025," as outlined in the provided text, could have several impacts on individuals and society. Here are three examples:
1. **Reduced Exposure to Misleading Information**: By restricting direct-to-consumer advertising for new drugs during the first three years after their approval, the legislation aims to reduce the likelihood that consumers will be exposed to potentially misleading or exaggerated claims about a drug's efficacy and safety. This could lead to more informed decision-making among patients and healthcare providers, ultimately resulting in better health outcomes.
2. **Encouragement of Informed Prescribing**: Physicians may benefit from the reduced promotional pressure associated with new drug advertisements. Without the influence of aggressive marketing campaigns, healthcare providers may rely more on clinical evidence and professional guidelines when prescribing medications. This could lead to a greater focus on patient-centered care and individualized treatment plans based on thorough evaluations rather than on information derived from advertisements.
3. **Impact on Drug Market Dynamics**: Pharmaceutical companies may experience changes in their marketing strategies and timelines for launching advertising campaigns. With the potential delay in direct-to-consumer advertising, companies might need to invest more in post-approval studies to gather evidence supporting their drugs' safety and effectiveness. This could lead to longer periods before a drug becomes widely known to consumers, potentially impacting sales and revenue for pharmaceutical companies. In turn, this might influence research and development priorities, possibly affecting the availability of new treatments for various conditions.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1117 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1117
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
to-consumer drug advertising.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 7, 2025
Ms. DeLauro introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to restrict direct-
to-consumer drug advertising.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Responsibility in Drug Advertising
Act of 2025''.
SEC. 2. DIRECT-TO-CONSUMER DRUG ADVERTISING.
The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) is
amended--
(1) in section 301 (21 U.S.C. 331), by adding at the end
the following:
``(jjj) The conduct of direct-to-consumer advertising of a drug in
violation of section 506M.''; and
(2) in chapter V, by inserting after section 506L (21
U.S.C. 356l) the following:
``SEC. 506M. DIRECT-TO-CONSUMER DRUG ADVERTISING.
``(a) Prohibitions.--
``(1) First 3 years.--
``(A) In general.--Subject to subparagraph (B), no
person shall conduct direct-to-consumer advertising,
including on a social media platform, of a drug
approved under section 505(c) before the end of the 3-
year period beginning on the date of such approval.
``(B) Waiver.--The Secretary may waive the
application of subparagraph (A) to a drug during the
third year of the 3-year period described in such
subparagraph if--
``(i) the sponsor of the drug submits an
application to the Secretary pursuant to
subparagraph (C); and
``(ii) the Secretary, after considering the
application and any accompanying materials,
determines that direct-to-consumer advertising
of the drug would have an affirmative value to
public health.
``(C) Application for waiver.--To seek a waiver
under subparagraph (B), the sponsor of a drug shall
submit an application to the Secretary at such time, in
such manner, and containing such information as the
Secretary may require.
``(2) Subsequent years.--The Secretary may prohibit direct-
to-consumer advertising, including on social media platforms,
of a drug during the period beginning at the end of the 3-year
period described in paragraph (1)(A) if the Secretary
determines that the drug has significant adverse health effects
based on post-approval studies, risk-benefit analyses, adverse
event reports, the scientific literature, any clinical or
observational studies, or any other appropriate resource.
``(b) Regulations.--Not later than 1 year after the date of the
enactment of this section, the Secretary shall revise the regulations
promulgated under this Act governing drug advertisements to the extent
necessary to implement this section.
``(c) Rule of Construction.--This section shall not be construed to
diminish the authority of the Secretary to prohibit or regulate direct-
to-consumer advertising of drugs, including on social media platforms,
under any other provision of law.
``(d) Effective Date.--This section applies only with respect to a
drug approved under section 505(c) on or after the date that is 1 year
before the date of enactment of this section.''.
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